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1、Azathioprine inthe management of Crohns diseaseRong ChenCaseMale,23 year old,history of Crohns disease,lower abdominal discomfort、vague pain、nausea and diarrhea for 3 days.Examination T:38.8, P:90/min, BP:12/8kPa,board-like rigidity and tight abdominal wall,tenderness and rebound tenderness especial
2、ly right lower quadrant. Punctate from right lower abdomen is purulent fluid.Blood WBC:21109/L, N80%, widal reaction(),CRP:13.7mg/L.Colonoscopy Scattered bleeding at ileocecal junction,2 erosions on the opposite side of ileocecal valve. Scattered ulcer-like erosions of the mucosa of mid-transverse c
3、olon.Primary diagnosis Ileocolitis Crohns diseaseQueries1、Besides corticosteroids,whether this case of Crohns disease take immunosuppressive therapy2、The curative effect of azathioprine or the outcome if azathioprine is used combine with corticosteroids PICOPatientsInterventionsComparisonsOutcomesQu
4、estion TypeDesign TypeIleocolitis, Crohns diseaseCorticosteroids+ AzathioprineCorticosteroids+ placeboRemission, ESR and CRP 、WBC decreaseTherapyRCT or System evaluationBackgroundThe aetiology of Crohns disease is unknown and as a result therapy options are limited. Corticosteroids, despite their si
5、de effects, remain the treatment modalities of choice. Intensive research has been directed at finding a safe and effective alternative to corticosteroids, particularly for use in resistant Crohns disease and the maintenance of remission. Immunosuppressive drugs such as azathioprine and its active m
6、etabolite, 6-mercaptopurine, have been used extensively in these clinical settings but their efficacy has yet to be proved unequivocally in controlled trials. SearchKey Words: Crohns disease Corticosteroids AzathioprineDatabase: Pubmed MedlineCandy S, Wrihgt J, Gerber M, Adams G, Gerig M, Goodman R.
7、 A controlled double blind study of azathioprine in the management of Crohns disease. Gut. 1995 Nov;37(5):674-8.DC, May GR, Fick GH, Sutherland LR. Azathioprine and 6-mercaptopurine in Crohn disease. A meta-analysis. Ann Intern Med. 1995 Jul 15;123(2):132-42. MethodsPatients: Patients between the ag
8、es of 15 and 65 years with confirmed Crohns disease who were being followed up at the Groote Schuur Hospital Inflammatory Bowel Disease Clinic provided the source population.Study drug: The azathioprine was in the form of film coated tablets.Study design: This was a single centre, two phase, double
9、blind, placebo controlled trial. MethodsEvaluation methods: The primary measure of therapeutic response was in each case the proportion of patients in remission. Secondary measures of therapeutic response were the median change in CDAI, ESR, serum CRP, serum orosomucoid concentration, and leucocyte
10、count between the first and last visits.Statistical methods: Two-tailed 2 test, Wilcoxon test, logistic regression test.ResultResultThere was no significant difference in the proportion of patients who had achieved and maintained remission by week 12 but at 15 months there was a highly significant d
11、ifference in the proportion of patients in remission (42% receiving azathioprine vs 7% receiving placebo), p=0.001. Evidence appraisalValidityImportanceApplicationValitidy1、Was the assignment of patients to treatment randomized? Yes2、Was the randomization concealed? Yes3、Were the groups similar at t
12、he start of the trial? Yes4、Was follow-up of patients sufficiently long and complete? YesValitidy5、were all patients analyzed in the groups to which they were? The study used an intention-to-treat analysis 6、Were patients, clinicians, and study personnel kept blind to treatment? The study is a contr
13、olled double blind trial7、Were groups treated equally, apart from the experimental therapy? YesImportance1、What is the magnitude of the treatment effect?ImportanceImportanceImportanceImportanceImportance2、How precise is this estimate of the treatment effect? 95%CI 1.6025.7Application1、Is our patient so different from those in the study that its result
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